Detalhe da pesquisa
1.
Exploring Greater Flexibility for Chronic Toxicity Study Designs to Support Human Safety Assessment While Balancing 3Rs Considerations.
Int J Toxicol;
: 10915818241255885, 2024 May 31.
Artigo
em Inglês
| MEDLINE
| ID: mdl-38822557
2.
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Regul Toxicol Pharmacol;
138: 105329, 2023 Feb.
Artigo
em Inglês
| MEDLINE
| ID: mdl-36592682
3.
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Regul Toxicol Pharmacol;
138: 105339, 2023 Feb.
Artigo
em Inglês
| MEDLINE
| ID: mdl-36649820
4.
Exploring the Definition of "Similar Toxicities": Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species.
Int J Toxicol;
41(3): 171-181, 2022.
Artigo
em Inglês
| MEDLINE
| ID: mdl-35435047
5.
The Use of Minipigs for Preclinical Safety Assessment by the Pharmaceutical Industry: Results of an IQ DruSafe Minipig Survey.
Toxicol Pathol;
44(3): 458-66, 2016 Apr.
Artigo
em Inglês
| MEDLINE
| ID: mdl-27006130
6.
Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.
Clin Pharmacol Ther;
109(6): 1395-1415, 2021 06.
Artigo
em Inglês
| MEDLINE
| ID: mdl-32757299
7.
An assessment of the central disposition of intranasally administered insulin lispro in the cerebrospinal fluid of healthy volunteers and beagle dogs.
Drug Deliv Transl Res;
7(1): 11-15, 2017 02.
Artigo
em Inglês
| MEDLINE
| ID: mdl-27553192
8.
A review of the abuse potential assessment of atomoxetine: a nonstimulant medication for attention-deficit/hyperactivity disorder.
Psychopharmacology (Berl);
226(2): 189-200, 2013 Mar.
Artigo
em Inglês
| MEDLINE
| ID: mdl-23397050